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目的:探讨艾迪注射液联合化学治疗治疗晚期非小细胞肺癌(NSCLC)的临床疗效及安全性。方法:582例晚期NSCLC患者随机分为观察组和对照组,对照组260例患者使用多西他赛联合顺铂或吉西他滨联合顺铂或长春瑞滨联合顺铂方案治疗,观察组322例患者在对照组的基础上加用艾迪注射液50 ml治疗,观察两组的近期疗效、不良反应和随访情况。结果:观察组和对照组的有效率分别为33.2%、33.1%(P>0.05),临床受益率81.1%、72.3%,比较差异有统计学意义(P<0.05);观察组的肿瘤进展时间、中位缓解期、中位生存期和1年生存率分别为16、22、40周和38%,对照组分别为15、21、41周和38%,两组比较差异无统计学意义(P>0.05);Ⅲ~Ⅳ度恶心、呕吐发生率分别为8%和16%,两组比较差异有统计学意义(P<0.05)。结论:与单纯化学治疗比较,艾迪注射液联合化学治疗能够提高晚期NSCLC患者临床受益率,减少不良反应,更易被患者接受。
Objective: To investigate the clinical efficacy and safety of Aidi injection combined with chemotherapy in the treatment of advanced non-small cell lung cancer (NSCLC). Methods: One hundred and fifty-two patients with advanced NSCLC were randomly divided into observation group and control group, and 260 patients in control group were treated with docetaxel plus cisplatin or gemcitabine combined with cisplatin or vinorelbine plus cisplatin. 322 patients On the basis of the control group plus Aidi Injection 50 ml treatment, the two groups were observed the short-term efficacy, adverse reactions and follow-up. Results: The effective rates of observation group and control group were 33.2% and 33.1% respectively (P> 0.05), and the clinical benefit rates were 81.1% and 72.3% respectively, with significant difference (P <0.05). The tumor progression time , Median remission, median survival and 1-year survival rates were 16, 22, 40, and 38% respectively, while those in control group were 15, 21, 41 and 38% respectively. There was no significant difference between the two groups P> 0.05). The incidences of grade Ⅲ ~ Ⅳ nausea and vomiting were 8% and 16%, respectively. There was significant difference between the two groups (P <0.05). Conclusion: Compared with the simple chemotherapy, Aidi injection combined with chemotherapy can improve the clinical benefit rate of patients with advanced NSCLC, reduce adverse reactions, and more easily accepted by patients.